Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Placebo

All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.

Simvastatin

All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk [ Time Frame: 7-10 days after hemorrhage ]

Measure Type

Primary

Measure Title

Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk

Measure Description

Resting cerebral blood flow during peak period of vasospasm risk measured by PET

Time Frame

7-10 days after hemorrhage

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Of the total population enrolled complete data sets were available on 25. This was due to patient refusal to perform the PET study, logistical difficulties and technical problems.

be completed in seven due to logistical difficulties (n = 4) or patient refusal (n = 3). Two of the completed studies could not be analyzed for technical reasons

Reporting Groups

Description

Simvastatin

Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.

Control

placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.

No statistical analysis provided for Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk

2. Primary:

Cerebral Autoregulation During Peak Period of Vasospasm Risk [ Time Frame: 7-10 days after hemorrhage ]

Measure Type

Primary

Measure Title

Cerebral Autoregulation During Peak Period of Vasospasm Risk

Measure Description

Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.

Time Frame

7-10 days after hemorrhage

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Simvastatin

Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.

Control

placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.

Measured Values

Simvastatin

Control

Participants Analyzed [Units: Participants]

13

12

Cerebral Autoregulation During Peak Period of Vasospasm Risk [Units: Participants]

2

2

No statistical analysis provided for Cerebral Autoregulation During Peak Period of Vasospasm Risk

3. Secondary:

Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk [ Time Frame: 7-10 days after hemorrhage ]

Measure Type

Secondary

Measure Title

Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk

Measure Description

Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.

Time Frame

7-10 days after hemorrhage

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Simvastatin, 80 mg/Day

Simvastatin, 80 mg/day for 21 days

Simvastatin, 80 mg/day for 21 days: Active treatment group

Placebo

Placebo

placebo: Control group

Measured Values

Simvastatin, 80 mg/Day

Placebo

Participants Analyzed [Units: Participants]

13

12

Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk [Units: Ratio]Mean (Standard Deviation)

.34 (.1)

.3 (.18)

No statistical analysis provided for Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk